RECRUITING

MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease

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Conditions

Sickle Cell Diseasefeasibility, music therapy, QoL, Sickle cell

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD). Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE). Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule. The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met. This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.

Official Title

MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)

Quick Facts

Study Start:2025-04-02
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06853158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be aged 14 years or older;
  2. 2. Have a diagnosis of SCD present in their electronic health record (EHR);
  3. 3. Meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain which includes:
  4. * Palpation of the region of reported pain elicits focal pain or tenderness;
  5. * Movement of the region of reported pain elicits focal pain;
  6. * Decreased range of motion or weakness in the region of reported pain;
  7. * Evidence of skin ulcer in the region of reported pain;
  8. * Evidence of hepatobiliary or splenic imaging abnormalities (e.g., splenic infarct, chronic pancreatitis) consistent with the region of reported pain; or
  9. * Evidence of imaging abnormalities consistent with bone infarction or avascular necrosis in the region of reported; (3d) There is no other diagnosis that better explains the signs and symptoms (to be obtained from providers following referral and pre-screening) (4) Be able to speak and understand English; (5) Have an email address and access to mobile device with a functioning data plan (6) Reporting that pain interfered with daily activities at least 1-2 days in the past week.
  1. 1. Have a significant visual, hearing, or cognitive impairment
  2. 2. Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
  3. 3. Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
  4. 4. Have a planned major medical event in the next 14 weeks such as (but not limited to) childbirth, orthopedic surgery, gene therapy, or stem cell transplant (These criteria do not include blood transfusions, exchange transfusions, or other pharmacologic pain treatment).

Contacts and Locations

Study Contact

Jeffery A Dusek, PhD
CONTACT
949-824-8841
jdusek@hs.uci.edu
Coretta Jenerette, PhD, RN
CONTACT
415-502-4242
Coretta.Jenerette@ucsf.edu

Principal Investigator

Jeffery A Dusek, PhD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center
Cleveland, Ohio, 44106
United States
Prisma Health Lifespan Comprehensive SCD Program
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Jeffery A Dusek, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-02
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-04-02
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • feasibility, music therapy, QoL, Sickle cell

Additional Relevant MeSH Terms

  • Sickle Cell Disease